Diabetic Foot UlcerNCT04577183
A Prospective, Open Label, Multicenter Trial for Evaluating the Efficacy of Treating and Managing Wounds in Elderly Population in Specialized Nursing Facilities Using RD1
A study testing RD1 System in people with Diabetic Foot Ulcer and Pressure Ulcer, run by RedDress Ltd. at 1 site in United States.
Trial summary
The study is a prospective, single arm, multicenter efficacy study, consisting of 60 subjects who will complete the study (note: if any patients are lost to follow-up or withdrawn, enrollment will increase to compensate for loss of these subjects). The subjects will receive up to 16 RD1 applications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Pressure Ulcer, Venous Leg Ulcer
- What is being tested?
- RD1 System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2018to 1 Feb 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥18 years of age
- Patient with a wound deemed suitable for treatment with RD1
- Ulcer free of clinical signs of infection.
- Post-debridement, ulcer free of necrotic tissue.
- For foot ulcers, Subject has adequate vascular perfusion of the affected limb, as defined by - Ankle-Brachial Index (ABI) ≥ 0.65 and ≤ 1.2
- HbA1c ≤ 12.0% (diabetic patients)
- Subject or legal authorized representative must be willing to comply with the protocol including having blood drawn to create the RD1.
- Female subjects who are capable of conceiving must use an acceptable form of contraception in order to participate in the study (acceptable forms of contraception include condoms for males and contraceptive pills or IUDs for women).
Who cannot join
- If ulcer area decreases by ≥ 30% during the initial 2-week screening (± 2 days) and standard of care phase, or if the ulcer area increases ≥ 30%,
- Presence of active underlying osteomyelitis.
- Patient with a proven sepsis established by a blood culture in the past 2 weeks, or confirmed active infection likely to interfere with trial, such as urine tract infection
- Known malignancy in the reference wound bed or margins of the wound
- Exposure of blood vessels or organs at the base of the reference wound
- History of alcohol or substance abuse, within the previous 2 months
Show all 16Show fewer
- Subject has participated in another clinical trial involving a device or a systemically administered investigational study drug or treatment within 30 days of day 0 visit.
- Subject is currently receiving (i.e., within the past 30 days) or scheduled to receive a medication or treatment which, in the opinion of the Investigator, is known to interfere with, or affect the rate and quality of, wound healing (e.g., systemic steroids (more than 10mg per day), immunosuppressive therapy, autoimmune disease therapy, cytostatic therapy within the past 12 months, dialysis, radiation therapy to the ulcer area, vascular surgery, angioplasty or thrombolysis).
- Subject has been treated with wound dressings that include growth factors, engineered tissues or skin substitutes within 30 days of randomization or is scheduled to receive during the study.
- Subject has been treated with hyperbaric oxygen within 5 days of screening or is scheduled to receive during the study.
- Wound on a patient who has a life expectancy of less than 6 months.
- Cannot withdraw blood in the required amount technically.
- Known coagulation problems, abnormal thrombocytes level or if heparin is given intravenously. Patients who are taking orally Coumadin, Aspirin, or Plavix (clopidogrel) will not be excluded.
- Hemoglobin anemia (< 9 g/dL).
- Subject has an infectious disease, such as Acquired Immune Deficiency Disease (AIDS) or HIV, Hepatitis C, Hepatitis B, Human T-lymphotropic virus or Syphilis
- Women who are pregnant or currently breast feeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sunnyview Nursing & Rehabilitation Center
Butler, Pennsylvania, 16001
About this study
Official title: A Prospective, Open Label, Multicenter Trial for Evaluating the Efficacy of Treating and Managing Wounds in Elderly Population in Specialized Nursing Facilities Using RedDress Wound Care System (RD1)
The study is a prospective, single arm, multicenter efficacy study, consisting of 60 subjects who will complete the study (note: if any patients are lost to follow-up or withdrawn, enrollment will increase to compensate for loss of these subjects). The subjects will receive up to 16 RD1 applications. In case of complete healing, subject will be called for one confirmatory visit two weeks later or before discharge from the SNF (the earlier of the two). Subject data will be kept in each site's records.
All diabetic subjects' glycemic management will be performed by a qualified physician. All subjects will have wound care specialist or wound surgeon or dermatologist involved in their wound care
- Conditions
- Diabetic Foot Ulcer, Pressure Ulcer, Venous Leg Ulcer, Trauma Injury, Skin Tear, Chronic Ulcer
- Being tested
- RD1 System
- Medical subject headings
- Diabetic Foot, Pressure Ulcer, Varicose Ulcer, Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RD1 SystemDevice
The RD1 is created by drawing the patient's blood with the use of citrate anticoagulant. The anticoagulant allows the clot to form later in a controlled fashion-citrate is a widely used anticoagulant. The blood is then placed in the clotting tray (within few minutes) and the coagulation is facilitated by adding calcium and kaolin (insoluble aluminum silicate). The forming clot assumes the shape of the tray containing it, and can then be applied to the wound, and then covered with primary and secondary dressings.
| Study group | Role | What they receive |
|---|---|---|
| RD1 System | Experimental | The RD1 is created by drawing the patient's blood with the use of citrate anticoagulant. The anticoagulant allows the clot to form later in a controlled fashion-citrate is a widely used anticoagulant. The blood is then placed in the clotting tray (within few minutes) and the coagulation is facilitated by adding calcium and kaolin (insoluble aluminum silicate). The forming clot assumes the shape of the tray containing it, and can then be applied to the wound, and then covered with primary and secondary dressings. Receives: Device: RD1 System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Reduction in Wound Size
Numer of patients showed Percent of wound reduction from baseline to end of treatment in the intent to treat (ITT) population
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start11 Jul 2018
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Why it stopped: operational challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- RedDress Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577183
- Sponsor's protocol ID
- RD004
- Status last verified
- Nov 2024
- First submitted
- 20 Mar 2019
- Last updated
- 2 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label, Multicenter Trial for Evaluating the Efficacy of Treating and Managing Wounds in Elderly Population in Specialized Nursing Facilities Using RedDress Wound Care System (RD1)
- ClinicalTrials.gov ID
- NCT04577183
- Acronym / sponsor ID
- RD004
- Conditions
- Diabetic Foot Ulcer, Pressure Ulcer, Venous Leg Ulcer, Trauma Injury, Skin Tear, Chronic Ulcer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: operational challenges
- Enrolment
- 13 participants (actual)
- Lead sponsor
- RedDress Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 6 Oct 2020 (actual)
- Results
- Posted 13 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a prospective, single arm, multicenter efficacy study, consisting of 60 subjects who will complete the study (note: if any patients are lost to follow-up or withdrawn, enrollment will increase to compensate for loss of these subjects). The subjects will receive up to 16 RD1 applications. In case of complete healing, subject will be called for one confirmatory visit two weeks later or before discharge from the SNF (the earlier of the two). Subject data will be kept in each site's records.
All diabetic subjects' glycemic management will be performed by a qualified physician. All subjects will have wound care specialist or wound surgeon or dermatologist involved in their wound care
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RD1 System | Experimental | Device: RD1 SystemThe RD1 is created by drawing the patient's blood with the use of citrate anticoagulant. The anticoagulant allows the clot to form later in a controlled fashion-citrate is a widely used anticoagulant. The blood is then placed in the clotting tray (within few minutes) and the coagulation is facilitated by adding calcium and kaolin (insoluble aluminum silicate). The forming clot assumes the shape of the tray containing it, and can then be applied to the wound, and then covered with primary and secondary dressings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is ≥18 years of age
- Patient with a wound deemed suitable for treatment with RD1
- Ulcer free of clinical signs of infection.
- Post-debridement, ulcer free of necrotic tissue.
- For foot ulcers, Subject has adequate vascular perfusion of the affected limb, as defined by - Ankle-Brachial Index (ABI) ≥ 0.65 and ≤ 1.2
Key exclusion criteria (16 listed)
- If ulcer area decreases by ≥ 30% during the initial 2-week screening (± 2 days) and standard of care phase, or if the ulcer area increases ≥ 30%,
- Presence of active underlying osteomyelitis.
- Patient with a proven sepsis established by a blood culture in the past 2 weeks, or confirmed active infection likely to interfere with trial, such as urine tract infection
- Known malignancy in the reference wound bed or margins of the wound
- Exposure of blood vessels or organs at the base of the reference wound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RD1 SystemThe RD1 is created by drawing the patient's blood with the use of citrate anticoagulant. The anticoagulant allows the clot to form later in a controlled fashion-citrate is a widely used anticoagulant. The blood is then placed in the clotting tray (within few minutes) and the coagulation is facilitated by adding calcium and kaolin (insoluble aluminum silicate). The forming clot assumes the shape of the tray containing it, and can then be applied to the wound, and then covered with primary and secondary dressings. | Device | RD1 System |
Primary outcome
Number of Participants With Reduction in Wound Size
Time frame: 16 weeks
Numer of patients showed Percent of wound reduction from baseline to end of treatment in the intent to treat (ITT) population
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RD1 System in people with Diabetic Foot Ulcer and Pressure Ulcer, run by RedDress Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Reduction in Wound Size (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.